6550--Binding Site Kappa/Lambda Light Chain and Hevylite Testing

Special Notice Special Notice Page 6 of 6 Special Notice *= Required Field Special Notice Page 1 of 6 DESCRIPTION NOTICE OF INTENT TO SOLICIT SOLE SOURCE Binding Site Free Kappa/Lambda and Hevylite Testing Reagents and Supplies Response Due Date: June 9th, by 4:00PM (EST) Requirement: The Department of Veterans Affairs, VISN 1, Pathology and Laboratory Medicine Service (P&LMS) requires a five-year-BPA for The Binding Site, Inc. Optilite Protein Analyzer and associated reagents, together with full maintenance and support including upgrades (Silver Level service pack). This requirement is for the equipment and reagents required to identify the special proteins related to multiple myeloma in Veteran patient cancer diagnosis. Specifically, testing of Free Light Chain Lambda and Kappa proteins as well as HevyLITE Assays of Light Chain proteins of Immunoglobulin G (IgG), Immunoglobin M (IgM) and Immunoglobin A (IgA) are required. Period of Performance: Year 1: 06/15/2025 06/14/2026 Year 2: 06/15/2026 06/14/2027 Year 3: 06/15/2027 06/14/2028 Year 4: 06/15/2028 06/14/2029 Year 5: 06/15/2029 06/14/2030 The authority for applying Simplified Procedures for Certain Commercial Products and Commercial Services under FAR 13.5 is - 10 U.S.C. 3205-3208 and 41 U.S.C.3305. The intent is to procure the referenced products on a sole source basis. No solicitation will be posted to Contract Opportunities. The North American Industry Classification System code (NAICS) for this requirement is 325413. All responsible sources that feel they should be considered qualified to provide the above-mentioned products may submit a response to this notice (by the response due date shown above) to Sarah.Otis@va.gov. The information provided shall include detailed (and relevant) documentation to allow the government to perform adequate market research and make a proper determination. A determination by the government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. REQUESTS FOR A SOLICITATION WILL NOT RECEIVE A RESPONSE. DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: Binding Site Free Kappa/Lambda and Hevylite Testing Contracting Activity: : Department of Veterans Affairs, Network Contracting Office 1 (NCO1); VISN 1, VISN 1 Network Consolidated Lab Nature and/or Description of the Action Being Processed: This procurement is for a new five-year-BPA for The Binding Site, Inc. Optilite Protein Analyzer and associated reagents, together with full maintenance and support including upgrades (Silver Level service pack). Period of performance is 6/15/2025 - 6/14/2030. This testing will be performed at the VAMC West Roxbury VA Immunology lab for all VISN 1 sites. Description of Supplies/Services Required to Meet the Agency s Needs: This requirement is for the equipment and reagents required to identify the special proteins related to multiple myeloma in Veteran patient cancer diagnosis. Specifically, testing of Free Light Chain Lambda and Kappa proteins as well as HevyLITE Assays of Light Chain proteins of Immunoglobulin G (IgG), Immunoglobin M (IgM) and Immunoglobin A (IgA) are required. The Binding Site, Inc., is the sole source provider for the HevyLITE reagents, and the Optilite Protein Analyzer that are used for this testing. The Binding Site, Inc. is the only vendor whose polyclonal assays are FDA approved for diagnosing and monitoring for therapy or disease progression. The technology is proprietary to The Binding Site. Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. - Competition is restricted on this procurement for the reason below: - - - - ( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements - - - - ( ) Unusual and Compelling Urgency - - - - ( ) - Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services - - - - ( ) International Agreement - - - - ( ) Authorized or Required by Statute - - - - ( ) National Security - - - - ( ) Public Interest Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This requirement is for the equipment and reagents required to identify the special proteins related to multiple myeloma in Veteran patient cancer diagnosis. Specifically, testing of Free Light Chain Lambda and Kappa proteins as well as HevyLITE Assays of Light Chain proteins of Immunoglobulin G (IgG), Immunoglobin M (IgM) and Immunoglobin A (IgA) are required. The Binding Site, Inc., is the sole source provider for the HevyLITE reagents, and the Optilite Protein Analyzer that are used for this testing. The Binding Site, Inc. is the only vendor whose polyclonal assays are FDA approved for diagnosing and monitoring for therapy or disease progression. The technology is proprietary to The Binding Site. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: No vendor other than The Binding Site Inc. offers HevyLITE testing. Searches were conducted for each of the products as well as the associated NAICS code 325413 across various government databases, including FPDS, SAM, GSA eLibrary, GSA Advantage, and DSBS, and no source other than The Binding Site Inc. was found. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Based on a comparison to the IGCE, the quote provided by The Binding Site Inc. was found to be XXX less than the estimate provided by the NCL based on past experience and ordering patterns. The most recent BPA held for these reagents by VISN 1, 36C24120A004, which was XXX, was later increased to a ceiling of XXX to reflect the actual needs of the patients being tested. Utilizing the Bureau of Labor Statistics CPI Inflation Calculator, this XXX would be adjusted from March 2020 to March 2025 and would equate to XXX. The actual total of the quote provided for the upcoming acquisition requirement is XXX The difference between these two totals is a mere XXX which also supports the determination that this procurement is fair and reasonable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Only The Binding Site Inc. was able to completely meet the requirements identified in the Statement of Work, and having the FDA approvals required by the VA . Any Other Facts Supporting the Use of Other than Full and Open Competition: None. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The COR will continue to monitor new technology and if additional comparable sources are found in the future, this requirement may be competed. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Wendy Strollo Date Network Consolidated Laboratory Director VISN 1 Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Make sure before submission for review that you have the below names completed. I did it this time. _____________________________ ________________________ Cynthia Thompson Date Contracting Officer NCO1-Manchester VAMC One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Sheryl Anthony Date Branch Chief NCO1 Bedford VAMC VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition. _____________________________ ________________________ Gerald F. Jacobs Date Executive Director, Regional Procurement Office East VHA Head of Contracting Activity (HCA)